A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma MONUMENTAL-2

What's the purpose of this trial?

The purpose of this study is to characterize the safety and tolerability of talquetamab when administered in different combination regimens and to identify the safe dose(s) of talquetamab combination regimens.

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

  • Have documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
  • Have measurable disease at screening as defined by at least 1 of the following: a. Serum monoclonal protein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL); or b. Urine M-protein level >= 200 milligrams (mg)/24 hours; or c. Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) >=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at screening and immediately before the start of study treatment administration
  • A woman of childbearing potential must have a negative highly sensitive serum beta human chorionic gonadotropin (beta-hCG) pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours before the start of study treatment administration
  • Be willing and able to adhere to the lifestyle restrictions specified in the protocol, including adherence to the applicable immunomodulatory drug (IMiD) global Pregnancy Prevention Plan (PPP) or local PPP/Risk Evaluation and Mitigation Strategy (REMS) program

Exclusion Criteria:

  • Live, attenuated vaccine within 4 weeks before the first dose of study treatment
  • Received a cumulative dose of corticosteroids equivalent to >=140 mg of prednisone within the 14-day period before the start of study treatment administration
  • Active central nervous system (CNS) involvement or exhibition of clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required
  • Known to be seropositive for human immunodeficiency virus
  • History of stroke or seizure within 6 months prior to the first dose of study treatment

Additional Trial Information

Phase 1

Enrollment: 182 patients (estimated)

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Published Results

Talquetamab + Pomalidomide in Patients with Relapsed/Refractory Multiple Myeloma: Safety and Preliminary Efficacy Results from the Phase 1b MonumenTAL-2 Study

December 11, 2023

Results: As of June 5, 2023, 35 patients were enrolled with a median follow-up of 11.4 months (range, 1.2–14.9) in the QW cohort (N=16) and 7.7 months (range, 1.6–10.8) in the Q2W cohort (N=19). Median ages were 69.5 years (range, 49–78) and 63.0 years (range, 43–76), respectively; 41.7% and 33.3% of pts had high-risk cytogenetics (del[17p], t[4;14], or t[14;16]) and 12.5% and 10.5% of pts had extramedullary disease, respectively. Median prior LOT were 3 in both cohorts; 25.0% and 21.1% were triple-class refractory, respectively, and 6.3% were penta-drug refractory (all in QW cohort). Prior treatments included CAR-T (18.8% and 0%), BsAb (6.3% and 0% [0% refractory]), and anti-CD38 Ab (75.0% and 73.7% [56.3% and 36.8% refractory]) in the QW and Q2W cohorts, respectively; 31.3% and 15.8% had prior pom exposure (18.8% and 5.3% refractory). All pts had ≥1 AE; most common were dysgeusia (77.1%), CRS (74.3%; most grade 1/2, 2.9% grade ≥3), and neutropenia (60.0%). Grade 3/4 AEs occurred in 88.6% of pts; most common were neutropenia (48.6%), anemia (25.7%), and thrombocytopenia (20.0%). Nail, skin, and rash toxicities occurred in 65.7%, 40.0%, and 20.0% of pts (majority grade 1/2 with no discontinuations), respectively. ICANS occurred in 2 pts (both grade 1). Infections occurred in 71.4% of pts (22.9% grade 3/4); most common were pneumonia (20.0%) and COVID-19 (14.3%). AEs led to dose reduction or schedule change of tal in 34.3% of pts and dose reduction of pom in 31.4% of pts. Two pts (5.7%) in the Q2W cohort had AEs, myocardial infarction and pulmonary embolism (PE), that led to treatment discontinuation (not drug related). One death due to PE occurred (same pt who discontinued treatment). ORR was 86.7% and 83.3% in the QW and Q2W cohorts, respectively, with ≥CR in 60.0% and 44.4% and ≥VGPR in 86.7% and 77.8%, respectively. ORRs were consistent across pt subgroups (>80% independent of prior pom or CAR-T exposure). Median time to first response was 1.0 month (range, 0.9–2.1) in the QW cohort and 1.3 months (range, 0–4.8) in the Q2W cohort. At 6 months, 100% of responders were still responding in both cohorts. Median DOR and PFS were not reached, with 6-month PFS rates of 93.3% (QW) and 88.9% (Q2W).

Conclusions: In this first reported combination of a GPRC5D-targeted therapy and an IMiD, tal + pom showed rapid, deep responses in pts with RRMM and ≥2 prior LOT. The safety profile of the combination, including grade 3/4 hematologic toxicity, was consistent with the individual agents, with no evidence of additive hematologic toxicities; additionally, there were low rates of treatment discontinuation due to AEs. The promising efficacy and manageable safety profile of this combination further supports tal as a versatile combination partner and warrants further evaluation of this regimen.

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Trial Locations

All Trial Locations

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Alabama

University of Alabama at Birmingham O'Neal Comprehensive Cancer Center

Birmingham, AL

Open and Accepting

California

UCSF Helen Diller Comprehensive Cancer Center University of California San Francisco

San Francisco, CA

Open and Accepting

Colorado

Colorado Blood Cancer Institute Sarah Cannon at Presbyterian/St. Luke's Medical Center (HealthONE)

Denver, CO

Open and Accepting

Georgia

Winship Cancer Institute Emory University

Atlanta, GA

Open and Accepting

Indiana

Simon Cancer Center Indiana University

Indianapolis, IN

Open and Accepting

New Jersey

John Theurer Cancer Center at Hackensack University Medical Center  Hackensack Meridian Health

Hackensack, NJ

Open and Accepting

New York

Mount Sinai Hospital Tisch Cancer Institute

New York, NY

Open and Accepting

Weill Cornell

New York, NY

Not Yet Accepting

North Carolina

Atrium Health's Levine Cancer Institute - Charlotte (Main) Atrium Health

Charlotte, NC

Open and Accepting

Pennsylvania

UPMC Hillman Cancer Center University of Pittsburgh Medical Center (UPMC)

Pittsburgh, PA

Open and Accepting

Tennessee

Sarah Cannon Research Institute at Tennessee Oncology TriStar Centennial Medical Center

Nashville, TN

Open and Accepting

Wisconsin

Medical College of Wisconsin Froedtert Hospital

Milwaukee, WI

Open and Accepting
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